A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00152477

Purpose

A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.

Condition	Intervention	Phase
Carcinoma Non-Squamous Non-Small-Cell Lung Cancer	Drug: Carboplatin Drug: Paclitaxel Drug: CDP791 10mg/kg Drug: CDP791 20mg/kg	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by UCB:

Primary Outcome Measures:

Tumour response rate at 18 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability [ Time Frame: analyzed alongside other parameters ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: at specified % event rates ] [ Designated as safety issue: No ]
Time to treatment failure [ Time Frame: analyzed alongside other parameters ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: at specified % event rates ] [ Designated as safety issue: No ]
Safety and Tolerability [ Time Frame: analyzed alongside other parameters ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: analyzed alongside other parameters ] [ Designated as safety issue: No ]

Enrollment:	165
Study Start Date:	August 2005
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Carboplatin/Paclitaxel: Experimental Carboplatin and paclitaxel alone.	Drug: Carboplatin 10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles. Drug: Paclitaxel 6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
Carboplatin/Paclitaxel/CDP791 10mg: Experimental Carboplatin and paclitaxel plus CDP791 10mg/kg	Drug: Carboplatin 10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles. Drug: Paclitaxel 6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles. Drug: CDP791 10mg/kg CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy. Drug: CDP791 20mg/kg CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
Carboplatin/Paclitaxel/CDP791 20mg: Experimental Carboplatin and paclitaxel plus CDP791 20mg/kg	Drug: Carboplatin 10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles. Drug: Paclitaxel 6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles. Drug: CDP791 10mg/kg CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy. Drug: CDP791 20mg/kg CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.

Detailed Description:

This is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small cell lung cancer.

In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of CDP791.

The main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus CDP791.

If part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2.

They will be randomized to receive either carboplatin/paclitaxel (C/P) alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy.

Participants will be followed up longterm, so that survival can be measured.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma.
The subject must be aged 18 years or above.
The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months.
Subjects will have measurable disease.
The subject must be able to understand the information provided to them and to give written informed consent.
Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator.
Male subjects must be using a method of contraception judged reliable by the Investigator.

Exclusion Criteria:

Subjects with squamous cell lung carcinoma.
Subjects with lung lesions located centrally in the chest that involve major blood vessels.
Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix.

Subjects with previous malignancies are eligible provided that they have been disease free for five years or more.

Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy.
Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2.
Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152477

Locations

Hungary

Matrahaza, Hungary

Budapest, Hungary

Pecs, Hungary

Nyiregyhaza, Hungary

Deszk, Hungary
Poland

Krakow, Poland

Poznan, Poland

Szczecin, Poland

Radom, Poland

Otwock, Poland

Zabrze, Poland

Warszawa, Poland

Poznan, Poland

Wroclaw, Poland

Olsztyn, Poland

Lodz, Poland

Lublin, Poland

Torun, Poland
Russian Federation

Moskow, Russian Federation

Moskow, Russian Federation

Samara, Russian Federation

Kazan, Russian Federation

Saint Petersburg, Russian Federation

Moscow, Russian Federation

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C79102, EudraCT 2005-001731-30
Study First Received:	September 6, 2005
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00152477 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by UCB:

Non-small-cell-lung cancer
carboplatin
paclitaxel
VEGF
monoclonal antibody

Study placed in the following topic categories:

Thoracic Neoplasms
Antimitotic Agents
Carboplatin
Carcinoma
Antibodies, Monoclonal
Antibodies
Respiratory Tract Diseases
Lung Neoplasms

Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Immunoglobulins

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 30, 2009